{
  "meta": {
    "data_length": 1,
    "message": "Statements retrieved successfully",
    "request_url": "http://api.moalmanac.org/statements?agent_id=agent%3Aorg%3Afda&proposition_id=prop%3Avtxr%3A361",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.004086,
    "timestamp_received": "2026-09-25T00:13:59.339910+00:00Z",
    "timestamp_returned": "2026-09-25T00:13:59.343996+00:00Z",
    "trace_id": "df2efaca-40b9-4fab-ad18-1ee1593929d2"
  },
  "service": {
    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-08-02"
  },
  "data": [
    {
      "id": "stmt:fda:iclusig:0:0",
      "type": "Statement",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to ponatinib in combination with chemotherapy for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The product label notes that this indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction and that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). This indication is based on PhALLCON (NCT03589326), a randomized, active-controlled, multicenter, open-label trial in which chemotherapy regimens were: vincristine and dexamethasone (induction, cycles 1 to 3); methotrexate and cytarabine (consolidation, cycles 4 to 9, alternating methotrexate and cytarabine); and vincristine and prednisone (maintenance, cycles 10 to 20).",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-30:0",
          "type": "Contribution",
          "description": "Initial access of FDA approvals",
          "date": "2024-10-30",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2024-03-19:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2024-03-19",
          "contributor": {
            "id": "agent:org:fda",
            "type": "Agent",
            "agentType": "organization",
            "name": "Food and Drug Administration",
            "description": "Regulatory agency that approves drugs for use in the United States."
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:fda:iclusig",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Iclusig (ponatinib) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Takeda Pharmaceuticals America, Inc. Iclusig (ponatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf. Revised March 2024. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203469"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Takeda Pharmaceuticals America, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Iclusig",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "ponatinib",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2012-12-14",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "identification_number",
              "value": 203469,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2024-03-19",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "direction": "supports",
      "proposition": {
        "id": "prop:vtxr:361",
        "type": "VariantTherapeuticResponseProposition",
        "predicate": "predictsSensitivityTo",
        "subjectVariant": {
          "type": "CategoricalVariant",
          "description": "Placeholder. Cat-VRS does not yet support sets of categorical variants. See the 'biomarkers' extension for biomarkers associated with this Proposition."
        },
        "conditionQualifier": {
          "id": "dis:oncotree:ALL",
          "conceptType": "Disease",
          "name": "Acute Lymphoid Leukemia",
          "mappings": [],
          "extensions": [
            {
              "name": "solid_tumor",
              "value": false,
              "description": "Boolean value for if this tumor type is categorized as a solid tumor."
            }
          ],
          "primaryCoding": {
            "id": "coding:oncotree:ALL",
            "code": "ALL",
            "name": "Acute Lymphoid Leukemia",
            "system": "https://oncotree.mskcc.org",
            "systemVersion": "oncotree_2021_11_02",
            "iris": [
              "https://oncotree.mskcc.org/?version=oncotree_2021_11_02&field=CODE&search=ALL"
            ]
          }
        },
        "objectTherapeutic": {
          "id": "txgrp:75",
          "membershipOperator": "AND",
          "therapies": [
            {
              "id": "tx:ncit:C408",
              "conceptType": "Therapy",
              "name": "Cytarabine",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:3041",
                    "code": "3041",
                    "name": "cytarabine",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=3041"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1311078",
                    "code": "1311078",
                    "name": "cytarabine",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1311078"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:387511003",
                    "code": "387511003",
                    "name": "Cytarabine",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387511003&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:4306038",
                    "code": "4306038",
                    "name": "Cytarabine",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4306038"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "DNA Polymerase inhibition"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Chemotherapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C408",
                "code": "C408",
                "name": "Cytarabine",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C408"
                ]
              }
            },
            {
              "id": "tx:ncit:C422",
              "conceptType": "Therapy",
              "name": "Dexamethasone",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:3264",
                    "code": "3264",
                    "name": "dexamethasone",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=3264"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1518254",
                    "code": "1518254",
                    "name": "dexamethasone",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1518254"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:372584003",
                    "code": "372584003",
                    "name": "Dexamethasone",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=372584003&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:4156734",
                    "code": "4156734",
                    "name": "Dexamethasone",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4156734"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Corticosteroid"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Chemotherapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C422",
                "code": "C422",
                "name": "Dexamethasone",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C422"
                ]
              }
            },
            {
              "id": "tx:ncit:C642",
              "conceptType": "Therapy",
              "name": "Methotrexate",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:6851",
                    "code": "6851",
                    "name": "methotrexate",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=6851"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1305058",
                    "code": "1305058",
                    "name": "methotrexate",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1305058"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:387381009",
                    "code": "387381009",
                    "name": "Methotrexate",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387381009&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:4301206",
                    "code": "4301206",
                    "name": "Methotrexate",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4301206"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Antifolate"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Chemotherapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C642",
                "code": "C642",
                "name": "Methotrexate",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C642"
                ]
              }
            },
            {
              "id": "tx:ncit:C95777",
              "conceptType": "Therapy",
              "name": "Ponatinib",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:1364347",
                    "code": "1364347",
                    "name": "ponatinib",
                    "system": "RxNorm",
                    "systemVersion": "20250602",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1364347"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:45771379",
                    "code": "45771379",
                    "name": "Ponatinib",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/45771379"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:703796003",
                    "code": "703796003",
                    "name": "Ponatinib",
                    "system": "SNOMED",
                    "systemVersion": "2026-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=703796003&edition=MAIN/2026-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:43013182",
                    "code": "43013182",
                    "name": "ponatinib",
                    "system": "OMOP",
                    "systemVersion": "v20250827",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/43013182"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "BCR-ABL inhibition"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Targeted therapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C95777",
                "code": "C95777",
                "name": "Ponatinib",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C95777"
                ]
              }
            },
            {
              "id": "tx:ncit:C770",
              "conceptType": "Therapy",
              "name": "Prednisone",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:8640",
                    "code": "8640",
                    "name": "prednisone",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=8640"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1551099",
                    "code": "1551099",
                    "name": "prednisone",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1551099"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:116602009",
                    "code": "116602009",
                    "name": "Prednisone",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=116602009&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:4023242",
                    "code": "4023242",
                    "name": "Prednisone",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4023242"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Corticosteroid"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Chemotherapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C770",
                "code": "C770",
                "name": "Prednisone",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C770"
                ]
              }
            },
            {
              "id": "tx:ncit:C933",
              "conceptType": "Therapy",
              "name": "Vincristine",
              "mappings": [
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:rxcui:11202",
                    "code": "11202",
                    "name": "vincristine",
                    "system": "RxNorm",
                    "systemVersion": "02-Mar-2026",
                    "iris": [
                      "https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=11202"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:1308290",
                    "code": "1308290",
                    "name": "vincristine",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/1308290"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:sctid:387126006",
                    "code": "387126006",
                    "name": "Vincristine",
                    "system": "SNOMED",
                    "systemVersion": "2025-03-01",
                    "iris": [
                      "https://browser.ihtsdotools.org/?perspective=full&conceptId1=387126006&edition=MAIN/2025-03-01&release=&languages=en"
                    ]
                  }
                },
                {
                  "relation": "relatedMatch",
                  "coding": {
                    "id": "coding:omop:4304296",
                    "code": "4304296",
                    "name": "Vincristine",
                    "system": "OMOP",
                    "systemVersion": "v20260227",
                    "iris": [
                      "https://athena.ohdsi.org/search-terms/terms/4304296"
                    ]
                  }
                }
              ],
              "extensions": [
                {
                  "name": "therapy_strategy",
                  "value": [
                    "Vinca alkaloid chemotherapy"
                  ],
                  "description": "Associated therapeutic strategy or mechanism of action of the therapy."
                },
                {
                  "name": "therapy_type",
                  "value": "Chemotherapy",
                  "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
                }
              ],
              "primaryCoding": {
                "id": "coding:ncit:C933",
                "code": "C933",
                "name": "Vincristine",
                "system": "https://evsexplore.semantics.cancer.gov",
                "systemVersion": "25.01d",
                "iris": [
                  "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C933"
                ]
              }
            }
          ]
        },
        "extensions": [
          {
            "name": "biomarkers",
            "value": [
              {
                "id": "bmkr.criterion:12",
                "present": true,
                "subject": {
                  "id": "bmkr:12",
                  "type": "CategoricalVariant",
                  "name": "BCR::ABL1",
                  "constraints": [
                    {
                      "type": "AdjacencyConstraint",
                      "orderKnown": true,
                      "adjoinedElements": [
                        {
                          "id": "gene:hgnc:1014",
                          "conceptType": "Gene",
                          "name": "BCR",
                          "primaryCoding": {
                            "id": "coding:hgnc:1014",
                            "code": "HGNC:1014",
                            "system": "https://genenames.org",
                            "iris": [
                              "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:1014"
                            ]
                          },
                          "mappings": [
                            {
                              "relation": "exactMatch",
                              "coding": {
                                "id": "coding:ensembl:ensg00000186716",
                                "code": "ENSG00000186716",
                                "system": "https://www.ensembl.org",
                                "iris": [
                                  "https://www.ensembl.org/id/ENSG00000186716"
                                ]
                              }
                            },
                            {
                              "relation": "exactMatch",
                              "coding": {
                                "id": "coding:ncbi:613",
                                "code": "613",
                                "system": "https://www.ncbi.nlm.nih.gov/gene",
                                "iris": [
                                  "https://www.ncbi.nlm.nih.gov/gene/613"
                                ]
                              }
                            },
                            {
                              "relation": "relatedMatch",
                              "coding": {
                                "id": "coding:refseq:NM_004327.4",
                                "code": "NM_004327.4",
                                "system": "https://www.ncbi.nlm.nih.gov/nuccore",
                                "iris": [
                                  "https://www.ncbi.nlm.nih.gov/nuccore/NM_004327.4"
                                ]
                              }
                            }
                          ]
                        },
                        {
                          "id": "gene:hgnc:76",
                          "conceptType": "Gene",
                          "name": "ABL1",
                          "primaryCoding": {
                            "id": "coding:hgnc:76",
                            "code": "HGNC:76",
                            "system": "https://genenames.org",
                            "iris": [
                              "https://www.genenames.org/data/gene-symbol-report/#!/hgnc_id/HGNC:76"
                            ]
                          },
                          "mappings": [
                            {
                              "relation": "exactMatch",
                              "coding": {
                                "id": "coding:ensembl:ensg00000097007",
                                "code": "ENSG00000097007",
                                "system": "https://www.ensembl.org",
                                "iris": [
                                  "https://www.ensembl.org/id/ENSG00000097007"
                                ]
                              }
                            },
                            {
                              "relation": "exactMatch",
                              "coding": {
                                "id": "coding:ncbi:25",
                                "code": "25",
                                "system": "https://www.ncbi.nlm.nih.gov/gene",
                                "iris": [
                                  "https://www.ncbi.nlm.nih.gov/gene/25"
                                ]
                              }
                            },
                            {
                              "relation": "relatedMatch",
                              "coding": {
                                "id": "coding:refseq:NM_005157.6",
                                "code": "NM_005157.6",
                                "system": "https://www.ncbi.nlm.nih.gov/nuccore",
                                "iris": [
                                  "https://www.ncbi.nlm.nih.gov/nuccore/NM_005157.6"
                                ]
                              }
                            }
                          ]
                        }
                      ]
                    }
                  ],
                  "extensions": [
                    {
                      "name": "biomarker_type",
                      "value": "Gene fusion"
                    }
                  ]
                }
              }
            ],
            "description": "The biomarkers associated with this Proposition, each with a `present` flag indicating if the biomarker is present (true) or absent (false). Multiple biomarkers are combined with implied AND logic."
          }
        ]
      },
      "strength": {
        "id": "str:ncit:C25425",
        "conceptType": "Evidence",
        "name": "Approval",
        "mappings": [],
        "primaryCoding": {
          "id": "coding:ncit:C25425",
          "code": "C25425",
          "name": "Approval",
          "system": "https://evsexplore.semantics.cancer.gov",
          "systemVersion": "25.01d",
          "iris": [
            "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25425"
          ]
        }
      },
      "extensions": [
        {
          "name": "status",
          "value": "Active",
          "description": "Whether this Statement is Active, Superseded, or Deprecated within moalmanac-db."
        },
        {
          "name": "indication",
          "value": {
            "id": "ind:fda:iclusig:0",
            "type": "Indication",
            "description": "ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).",
            "contributions": [
              {
                "id": "ctrb:vanallenlab:2024-10-30:0",
                "type": "Contribution",
                "description": "Initial access of FDA approvals",
                "date": "2024-10-30",
                "contributor": {
                  "id": "agent:user:vanallenlab",
                  "type": "Agent",
                  "agentType": "contributor",
                  "name": "Van Allen lab",
                  "description": "Van Allen lab, Dana-Farber Cancer Institute"
                }
              },
              {
                "id": "ctrb:fda:2024-03-19:0",
                "type": "Contribution",
                "description": "Indication received traditional approval.",
                "date": "2024-03-19",
                "contributor": {
                  "id": "agent:org:fda",
                  "type": "Agent",
                  "agentType": "organization",
                  "name": "Food and Drug Administration",
                  "description": "Regulatory agency that approves drugs for use in the United States."
                }
              }
            ],
            "reportedIn": [
              {
                "id": "doc:fda:iclusig",
                "type": "Document",
                "documentType": "Regulatory approval",
                "name": "Iclusig (ponatinib) [package insert]. FDA.",
                "title": null,
                "aliases": [],
                "description": "Takeda Pharmaceuticals America, Inc. Iclusig (ponatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf. Revised March 2024. Accessed October 30, 2024.",
                "urls": [
                  "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf",
                  "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203469"
                ],
                "doi": null,
                "pmid": null,
                "extensions": [
                  {
                    "name": "agent",
                    "value": {
                      "id": "agent:org:fda",
                      "type": "Agent",
                      "agentType": "organization",
                      "name": "Food and Drug Administration",
                      "description": "Regulatory agency that approves drugs for use in the United States."
                    },
                    "description": "The organization that published this document."
                  },
                  {
                    "name": "company",
                    "value": "Takeda Pharmaceuticals America, Inc.",
                    "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_brand",
                    "value": "Iclusig",
                    "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "drug_name_generic",
                    "value": "ponatinib",
                    "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
                  },
                  {
                    "name": "first_publication_date",
                    "value": "2012-12-14",
                    "description": "The publication date for the initial version of this document."
                  },
                  {
                    "name": "identification_number",
                    "value": 203469,
                    "description": "Identification number used by the publishing organization."
                  },
                  {
                    "name": "publication_date",
                    "value": "2024-03-19",
                    "description": "The publication date for the document."
                  },
                  {
                    "name": "status",
                    "value": "Active",
                    "description": "Whether this document is Active or Deprecated within moalmanac-db."
                  }
                ]
              }
            ],
            "extensions": [
              {
                "name": "status",
                "value": "Approved",
                "description": "Current approval status."
              }
            ]
          },
          "description": "The underlying Indication supporting this Statement."
        }
      ]
    }
  ]
}